Veridex, Cell Search Circulating Tumor Cell Control Kit. Product code 7900003
FDA device recall Z-1472-2011 · posted 2011-03-01 · Terminated
Recall details
- Recalling firm
- Veridex, LLC
- Reason for recall
- There is a discrepancy between the assigned range of values on the high control label and the range listed on the Cell control Assigned Value Label for the Cell Search Circulating Tumor Cell Control Kit.
- Action taken
- Veridex notified all affected consignees on November 11, 2010 by Federal Express overnight letter and prodivded with the informaiton regarding the label discrepancy. Foreign consignees were also notified on November 11, 2010 of the issue and instructed to notify their affected consignees. Consignees are asked to return the confirmation of receipt form by 11/29/2010.
- Root cause
- Process control
- Status
- Terminated
- Product code
- NRS
- Quantity affected
- 122 US, 28 International
- Distribution
- Worldwide distribution, including: USA, Canada, France, UK, Germany, Italy, China, Spain & Portugal.
- Date initiated
- 2010-11-09
- Date posted
- 2011-03-01
- Date terminated
- 2014-03-28
- Location
- Raritan, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CELLSEARCH EPITHELIAL CELL CONTROL KIT (K040898) | Veridex, LLC | 2004-06-28 |